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Abstract
Objective: To assess whether adding clopidogrel to acetylsalicylic acid (ASA) has a long-term protective vascular effect in patients with lacunar stroke while taking ASA.
Methods: Post hoc analysis of 838 patients with ASA failure and recent lacunar stroke from the Secondary Prevention of Small Subcortical Strokes Trial (SPS3) cohort randomly allocated to aspirin (325 mg/day) and clopidogrel (75 mg/day) or placebo. Primary efficacy outcome was stroke recurrence (ischemic and intracranial hemorrhage) and main safety outcome was major extracranial hemorrhage. Patients were followed for a mean period of 3.5 years.
Results: The ASA failure group had a significantly higher risk of vascular events including ischemic stroke when compared with the non–ASA failure group (n = 2,151) in SPS3 (p = 0.03). Mean age was 65.6 years and 65% were men. The risk of recurrent stroke was not reduced in the dual antiplatelet group, 3.1% per year, compared to the aspirin-only group, 3.3% per year (hazard ratio [HR] 0.91; 95% confidence interval [CI] 0.61–1.37). There was also no difference between groups for ischemic stroke (HR 0.90; 95% CI 0.59–1.38). The risk of gastrointestinal bleeding was higher in the dual antiplatelet group (HR 2.7; 95% CI 1.1–6.9); however, the risk of intracranial hemorrhage was not different.
Conclusions: In patients with a recent lacunar stroke while taking ASA, the addition of clopidogrel did not result in reduction of vascular events vs continuing ASA only.
Classification of evidence: This study provides Class I evidence that for patients with recent lacunar stroke while taking ASA, adding clopidogrel as compared to continuing ASA alone does not reduce the risk of recurrent stroke.
GLOSSARY
- ASA=
- acetylsalicylic acid;
- CI=
- confidence interval;
- HR=
- hazard ratio;
- SPS3=
- Secondary Prevention of Small Subcortical Strokes Trial
Footnotes
Go to Neurology.org for full disclosures. Funding information and disclosures deemed relevant by the authors, if any, are provided at the end of the article.
Editorial, page 376
- Received April 30, 2013.
- Accepted in final form September 3, 2013.
- © 2014 American Academy of Neurology
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